BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2832636 · Received November 14, 2012

    Report

    Report Number
    3004939290-2012-00422
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 17, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INFORMATION PROVIDED AND NO RETURNED DEVICE FOR PHYSICAL INVESTIGATION, THE REPORTED EVENT COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (LOT F1209404) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI DISTRIBUTOR THAT A PATIENT UNDERWENT A CATHETERIZATION PROCEDURE ON AN UNKNOWN DATE. ACCESS WAS OBTAINED VIA A 6F TERUMO SHEATH. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS A TRAINED USER, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE PEG (SEALANT) GOT STUCK TO THE TIP OF THE SHUTTLE/SEALANT SLEEVE AFTER UNSHEATHING THE SEALANT. THE DEVICE WAS REMOVED AND THE PATIENT WAS CONVERTED TO MANUAL COMPRESSION (DURATION UNKNOWN). NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 F1209404

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention